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Scientists Advancing Affordable Medicines, Inc. is a nonprofit 501(c)(6) organization that seeks to provide a dedicated platform for scientists to share cutting-edge research that facilitates the development of high-quality, affordable medicines, thereby improving their accessibility to patients. Because we are sharing approaches now for the affordable medicines of tomorrow, we have adopted the tradename SAAMnow.
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Meeting the Challenges of Biosimilar Product Approval
Wednesday, June 7th | 12:00 pm EDT (Eastern US) | Duration: 90 minutesSAAMnow will be presenting an important webinar about addressing the challenges facing the development of Biosimilar drug products on June 7th, 2023. This webinar will include two presenters. First, you will hear from Susan Kirshner, Ph.D., Director of the FDA’s Division of Biotechnology Review and Research III who will provide valuable information about meeting the FDA’s requirements for assessing the potential immunogenicity of your prospective product. Next, Jeffery Baker, Ph.D., Sr. Fellow, NIIMBL and Sr. Strategic Advisor at MIT’s Center for Biomedical Innovation and former Deputy Director of FDA’s Office of Biotechnology Products, will discuss the myriad challenges that companies face beyond the demonstration of biosimilarity. Registration is free for attendees. Current members of SAAMnow will have online access to content from these webinars. Non-members will have live access to the webinars for which they registered but will not have access to the content after those events have ended.
Why Should You Attend:
This webinar will provide valuable information for those working on the development of, or considering developing, biosimilar drug products.
Join SAAMnow
SAAMnow offers individuals the opportunity to potentially impact the availability of affordable medicines through cutting-edge research. SAAMnow is looking for individuals involved/interested in research & development, formulation/manufacturing science, analytical chemistry, clinical science, statistics, quality systems, regulatory science, marketing, and allied disciplines associated with the development, manufacturing, testing, and commercialization of high quality affordable medicines. Affordable medicines are broadly defined as those that take advantage of abbreviated regulatory filing pathways, resulting in development cost savings that can then be passed on to patients. Examples include conventional generic pharmaceuticals, biosimilars, and products filed via hybrid regulatory pathways, such as the 505(b)(2) route.
Our annual membership dues: $50.
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